Qualification of PAT Based Control Strategies for Batch and Continuous Manufacturing

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Recording for ISPE Members will be available on 25 October 2019.

On- and in-line analysers are used in the framework of PAT (Process Analytical Technology) for controlling and monitoring unit operations in pharmaceutical operations for both batch and continuous manufacturing. The most basic requirement to utilize this technology in a GMP environment is that the instruments and their interfaces are commissioned and qualified before proceeding to the analytical method validation and productive use. A PAT system cannot be regarded as a stand-alone analytical lab instrument or as a piece of manufacturing equipment.

The purpose of this webinar is to provide practical examples highlighting different approaches how to commission, qualify and verify PAT systems designated for sophisticated control strategies in the most efficient and resource-saving way. The PAT systems would typically include:

  • An analytical equipment with PC based control
  • Physical interfaces via a probe to the manufacturing equipment
  • Data interfaces to the process control system and other data bases such as historians, MES or LIMS systems
  • Feedback and feedforward control loop
  • Reporting and storage functionalities
Process Analytical Technology

The webinar will address the following questions:

  • Is qualification always required when introducing PAT analysers into manufacturing?
  • What is the instrument vendor covering during C&Q?
  • How is the qualification task linked to method validation of the same PAT system?
  • What does a science & risk-based approach to qualification of PAT systems look like?
  • What are important points to be considered when defining the URS for a PAT based control system and what are typical pitfalls?
  • How should the integration and automation part be handled during qualification?
  • What is expected in terms of cost and resources?

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Meet the Speakers:

Lorenz Liesum, PhD
Global PAT Head, Manufacturing Science and Technology
Novartis Technical Operations

Lorenz studied Chemistry and Mathematics and holds a Ph.D. in Physical Chemistry from ETH Zurich. He started his industrial career as an analytical scientist in chemical and pharmaceutical development at Roche and Novartis. Since more than 10 years he is working in the field of Process Analytical Technology and was involved in regulatory QbD filings. He is leading the Statistics and PAT group within global Manufacturing Science and Technology in Novartis Technical Operation supporting the production sites globally for all statistical relevant topics and managing PAT and QbD implementation with a strong focus on advanced control strategies based on NIR spectroscopy and multivariate statistical process control. 

Martin Warman
Martin Warman Consultancy Ltd

He spent 7 years at Vertex, developing the Vertex continuous manufacturing (CM) platform, on which the first approved CM products are manufactured. He has over 25 years’ experience in the field having previously led the Global PAT Development Team, Pfizer Global Manufacturing. Martin is on the Exec Committee of ASTM E55, chairing ASTM E55.01 PAT, is on the ISPE PAT Community of Practice (CoP) global steering committee, and chairs the UK Affiliate PAT CoP. Part of this role at University of Strathclyde includes supporting the Centre for Process Analytics and Control Technology (CPACT) and CMAC Future Manufacturing Research Hub as well as being on Technical Advisory Committee (TAC) for the new Medicines Manufacturing Innovation Centre (MMIC) being built in Renfrewshire, Scotland.

Line Lundsberg-Nielsen, PhD
Managing Consultant

Line is a physicist working as a Managing Consultant at NNE. She holds a Ph.D. in NIR spectroscopy.  Her background is pharmaceutical manufacturing and development. She works as a consultant focusing on Science & Risk based approaches in terms of QbD, PAT, Control Strategy, Process Validation, Qualification and Pharma 4.0. Line has been a member of ISPE for +15 years and has served many roles. She is currently the co-chair of the global PAT & LCS CoP. 

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